MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F (DUAL-LUM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redy1077 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported when one of our intensivists opened the kit to place the line, he found a large strand of hair packaged in the sterile supplies.The kit was not utilized and there was no harm to the patient.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hair in a kit is inconclusive due to the state of the returned sample.One 13 fr duoglide kit was returned for evaluation.An initial visual observation showed the kit was returned open and the kit components were strewn about the open packaging.No blood residue or other evidence of use was observed on any of the returned components.No hair was found within the kit packaging or on any of the kit components.No hair or other foreign material was found within the returned kit; however, because the kit was returned open, it was not possible to confirm or unconfirm the alleged issue.A lot history review (lhr) of redy1077 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported when one of our intensivists opened the kit to place the line, he found a large strand of hair packaged in the sterile supplies.The kit was not utilized and there was no harm to the patient.

• Brand Name: DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F (DUAL-LUM
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10146024
• MDR Text Key: 195289895
• Report Number: 3006260740-2020-02078
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741042096
• UDI-Public: (01)00801741042096
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 5625150
• Device Lot Number: REDY1077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1